Asparaginase medac
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Asparaginase medak is an antitumor drug.
Release form and composition
Asparaginase medak is produced in the form of a lyophilisate for the preparation of a solution for intramuscular and intravenous administration, which is a white or almost white mass or powder (5000 IU or 10,000 IU in vials, one vial in a cardboard box, five cardboard boxes packed in a polymer transparent film).
The composition of 1 bottle with lyophilisate contains the active ingredient - L-asparaginase - 5000 IU or 10,000 IU.
Indications for use
Asparaginase medak is used for the treatment of lymphoblastic non-Hodgkin's lymphomas (reticulo- and lymphosarcomas), as well as as part of complex treatment for the induction of remission in acute lymphoblastic leukemia.
The drug is not recommended to be included in the maintenance therapy regimens, since resistance to it develops rather quickly.
Contraindications
- severe impairment of renal and / or hepatic function;
- pancreatitis (in history or at the time of initiation of therapy);
- period of pregnancy;
- lactation period;
- allergic reactions caused by taking asparaginase (in history).
Method of administration and dosage
The first injections of Asparaginase medak are recommended under the supervision of a specialist with relevant experience in chemotherapy.
The solution is administered intramuscularly, intravenously, or as a slow intravenous infusion (for at least 30 minutes).
The drug is used both separately and in combination with other cytostatic agents.
Asparaginase medak is administered intramuscularly or intravenously at a dose of 6000-10,000 IU / m2 of body surface every day or every other day until the total dose is 400,000 IU (no more).
When administered intramuscularly, no more than 2 ml of solution can be injected into one place. If a single dose exceeds this amount, several injections are given at different sites.
Before the first injection of the drug, as well as if one week or more has passed between injections, it is recommended to conduct an intradermal test to predict allergic reactions to L-asparaginase. For this, the lyophilisate is dissolved in water for injection until an asparaginase concentration of 100 IU / ml is obtained. Then, about 10 IU (0.1 ml) of the resulting solution is injected intradermally and the reaction is monitored for one hour. In case of hyperemia or the formation of papules more than 1 cm in diameter, the reaction to asparaginase is considered positive, therefore, drug treatment should be refrained from. In case of intravenous administration of Asparaginase, medak, in addition to an intradermal test, is administered a trial intravenous dose (1 hour before treatment at a dose of 1000 IU intravenously for a short time).
To prepare the solution, 2 ml of water for injection is added to a bottle with a powder at a dose of 5000 IU, and 4 ml is added to a bottle with a powder at a dose of 10,000 IU. To avoid the formation of foam, water is poured slowly along the inner wall of the bottle, and when the contents are dissolved, the bottle is not shaken, but rotated.
The prepared solution of Asparaginase medak can slightly opalesce.
When injected intramuscularly, the solution is ready for use; it does not need to be diluted further.
For slow intravenous infusion, the prepared solution with the calculated amount of asparaginase is diluted in 250-500 ml of 5% glucose or isotonic sodium chloride solution, for intravenous jet injection - in 20-40 ml.
Side effects
- digestive system: acute pancreatitis, dysfunction of the pancreas; rarely - hemorrhagic pancreatitis; in some cases - vomiting, nausea, anorexia, the formation of pseudocysts (can occur within 4 months after the end of therapy, therefore, during this time the patient should be monitored using appropriate techniques), liver dysfunction, a decrease in serum albumin levels, cholestasis; in isolated cases - necrosis of liver cells, jaundice;
- central nervous system: confusion, pathological drowsiness, lethargy; in some cases, convulsions;
- coagulation system: thromboembolism, decreased levels of protein C, fibrinogen, plasminogen, antithrombin III, factor X and XI; in some cases - hemolytic anemia;
- metabolism: decreased insulin levels and glucose tolerance; often - hyperglycemia; in some cases, ketoacidosis;
- endocrine system: in some cases - a decrease in the level of thyroxine-binding protein, transient and secondary hypothyroidism;
- urinary system: rarely - impaired renal function, hyperuricemia;
- dermatological reactions: in isolated cases - toxic epidermal necrolysis;
- allergic reactions: often - hypersensitivity reactions (blisters and / or rash); sometimes - respiratory failure, anaphylactic shock with a fatal outcome; 2-5 hours after administration - chills, increased body temperature (pass on their own); rarely - life-threatening fever.
special instructions
With the development of allergic reactions, the administration of Asparaginase medak should be stopped immediately and appropriate measures should be taken (administration of glucocorticosteroids, antihistamines, drugs that stabilize hemodynamic parameters).
In patients with a clinical predisposition to bleeding with a significant decrease in the content of coagulation factors, replacement therapy with fresh frozen plasma should be performed.
During the period of drug treatment, it is recommended to regularly monitor blood clotting indicators and glucose in urine and blood.
Patients should avoid consuming ethanol.
Asparaginase medak can reduce the rate of psychomotor reactions, especially with the simultaneous use of alcohol, therefore, during treatment, it is advisable to abandon the control of potentially dangerous mechanisms.
Drug interactions
Prednisolone and vincristine increase the risk of asparaginase toxicity (impaired erythropoiesis, increased risk of neuropathies, increased hyperglycemic effect of asparaginase).
Cytarabine and methotrexate, introduced before Asparaginase medac, synergistically enhance its effect, if asparaginase is administered first, an antagonistic effect is observed and the effect of the drug is weakened.
Asparaginase can increase the toxicity of other drugs by affecting liver function.
With simultaneous use with uricosuric anti-gout drugs, the risk of nephropathy increases, which is associated with overproduction of uric acid.
Terms and conditions of storage
Store in a dark place at room temperature. Keep out of the reach of children.
Shelf life is 2 years.
The prepared solution must be used within 6 hours; it is not intended for reuse.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
